Treats HIV-1 infection. NDA 208215, held by Gilead Sciences Inc. Emtricitabine; Tenofovir Alafenamide Fumarate.
As of Nov 14, 2026, NDA 208215 (Descovy), held by Gilead Sciences Inc, was first approved by FDA on Apr 4, 2016, with 10 approved supplements and 0 published complete response letters.
HIV-1 Treatment: DESCOVY is a two-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and adolescent patients weighing at least 35 kg. for the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg to less than 35 kg in combination with other antiretroviral agents, including darunavir and cobicistat but not other protease inhibitors that require a CYP3A inhibitor.
| Jun 20, 2025 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Jun 20, 2025 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | |
| Jan 7, 2022 | Supplement 20Efficacy (new indication or use) · Priority review | Approved | |
| Dec 3, 2019 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Oct 3, 2019 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Sep 28, 2017 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Apr 4, 2016 | Original applicationNew combination · Standard review | Approved |
| Descovy200MG;EQ 25MG BASE · tablet;oral | Emtricitabine; Tenofovir Alafenamide Fumarate | RxReference drug |
| Descovy120MG;EQ 15MG BASE · tablet;oral | Emtricitabine; Tenofovir Alafenamide Fumarate | RxReference drug |
| Jun 20, 2025 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Jun 20, 2025 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | |
| Jan 7, 2022 | Supplement 20Efficacy (new indication or use) · Priority review | Approved | |
| Sep 15, 2021 | Supplement 19Labeling · Standard review | Approved | |
| Mar 4, 2021 | Supplement 17Labeling · Standard review | Approved | |
| Nov 24, 2020 | Supplement 14Manufacturing · Standard review | Approved | |
| Dec 3, 2019 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Oct 3, 2019 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Sep 28, 2017 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Apr 7, 2017 | Supplement 1Labeling · Standard review | Approved | |
| Apr 4, 2016 | Original applicationNew combination · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
